Drug product
Epinephrine (L-Adrenaline), USP, CAS 51-43-4, Packaged in amber glass bottles in a vacuum sealed pouch as (a)100 G; (b)1 G, (c) 25 G, (d) 5 G; Rx only. Repackaged by Spectrum Chemical Mfg. Corp. Gardena, CA 90248; New Brunswick, NJ 08901.
D-0180-2023
Product summary
- Event
- Event 91381
- Status
- Terminated
- Classification
- Class I
- Quantity
- 7 x 100G; 17 x 1G; 6 x 25G; 20 x 5G
- Official record key
drug-enforcement:D-0180-2023
Official wording
Reason: Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Code information: Lot # (a) (b) (c) (d) lot 2KL0353, EXP 30-Sep-2023; 2KF0151, EXP 31-Mar-2023
Distribution pattern: Nationwide in the USA, Puerto Rico and Canada
Derived failure modes
-
Unknown
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product